FDA Approves Expanded Adjuvant Indications for Herceptin

Article

US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

US Food and Drug Administration’s Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

Herceptin can now be included as part of a treatment regimen containing doxorubicin, cyclophosphamide, and docetaxel, and also as part of another regimen containing docetaxel and carboplatin, for the adjuvant treatment of HER2 overexpressing, node-positive, or high-risk node-negative breast cancer.

Herceptin first received FDA approval in September 1998 for use in women with metastatic breast cancer, as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy.

In January 2008, Herceptin was also approved as a single agent for the adjuvant treatment of HER2-overexpressing node-negative or node-positive breast cancer, following multimodality anthracycline-based therapy.

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Recent Videos
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Related Content
© 2025 MJH Life Sciences

All rights reserved.